[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Sinomune Pharmaceutical Co., Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":70},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100644004","phase-1-a-phase-1b-study-of-zyg24004-in-participants-with-tinea-pedis-caused-by-dermatophytes-100644004",false,"NCT07668999","A Phase 1b Study of ZYG24004 in Participants With Tinea Pedis Caused by Dermatophytes","A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Different Concentrations of ZYG24004 in Participants With Tinea Pedis Caused by Dermatophytes","Inclusion Criteria:\n\n1. Male or female participants aged 18 to 65 years; body weight \\>=50 kg for males and \\>=45 kg for females; body mass index (BMI) 18.5 to 28.0 kg\u002Fm2, inclusive.\n2. Clinically diagnosed tinea pedis, with lesions located in the interdigital area and possibly involving the sole and lateral foot.\n3. Positive mycological test of the target foot at screening, based on fungal microscopy.\n4. Target-foot clinical signs and symptoms score \\>=3.\n5. In generally good health, with no serious or uncontrolled systemic disease, and considered by the investigator to be suitable for participation.\n6. The participant or the participant's partner is not pregnant or breastfeeding, and the participant agrees to use reliable contraception throughout the study and for 3 months after the last administration.\n7. Willing and able to comply with scheduled visits and protocol requirements, and able to understand and sign the informed consent form.\n\nExclusion Criteria:\n\n1. Hyperkeratotic tinea pedis, or tinea pedis accompanied by erosion, exudation, or ulceration.\n2. Concomitant onychomycosis of the feet or other active fungal disease.\n3. Bacterial or viral skin infection of the feet, or severe skin disease judged by the investigator to affect study assessments, such as severe eczema, psoriasis, atopic dermatitis, or chronic dermatitis.\n4. History of dermatophyte infection that was ineffective to prior antifungal therapy.\n5. Use of systemic antifungal drugs within 3 months before enrollment.\n6. Use of topical antifungal drugs, such as terbinafine cream, butenafine cream, ciclopirox, clotrimazole, or miconazole, or topical corticosteroid-containing drugs within 4 weeks before enrollment.\n7. Use of topical antibacterial drugs, disinfectants, keratolytic agents such as salicylic acid, or other topical treatment on the feet within 2 weeks before enrollment.\n8. Use of oral antihistamines within 1 week before enrollment.\n9. Use of systemic corticosteroids or immunosuppressive drugs within 4 weeks before enrollment.\n10. Serious or uncontrolled cardiovascular, hepatic, renal, neurological, psychiatric, or immune system disease.\n11. History of diabetes mellitus or fasting blood glucose above the upper limit of normal.\n12. Clinically significant abnormalities in physical examination, hematology, blood chemistry, urinalysis, 12-lead electrocardiogram, infectious disease screening, coagulation function, or other assessments.\n13. Currently participating in another clinical trial, or participation in another clinical trial within 30 days before the baseline visit or within 5 half-lives of the investigational product, whichever is longer.\n14. Known severe allergy or intolerance to ZYG24004 or any excipients of the formulation, including film-forming polymers or ethanol.\n15. Addiction to smoking, defined as \\>10 cigarettes per day.\n16. Diagnosis of alcohol dependence or drug dependence within the past 12 months, or any situation judged by the investigator to affect compliance.\n17. Any other condition that, in the investigator's opinion, may interfere with study results or make participation unsafe.","ALL","18 Years","65 Years",{"count":20,"type":21},64,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This is a multicenter, randomized, double-blind, placebo-controlled Phase 1b study in adult participants with tinea pedis caused by dermatophytes. The study will evaluate the safety, local tolerability, and pharmacokinetic profile of two concentrations of ZYG24004 (1% and 3%) after topical administration once or twice (once weekly for two consecutive weeks), and will explore preliminary efficacy.",[27],"Tinea Pedis",[29,30,31,32],"ZYG24004","tinea pedis","Phase 1b","topical film-forming formulation","NOT_YET_RECRUITING","2026-06-21",{"date":36,"type":37},"2026-06-25","ACTUAL",{"date":39,"type":21},"2026-07-03",{"date":41,"type":21},"2027-06-10",{"name":43,"class":44},"Sinomune Pharmaceutical Co., Ltd","INDUSTRY",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":45},"100624007","phase-1-zyg24002-lotion-to-evaluate-the-safety-tolerability-pharmacokinetics-and-preliminary-efficacy-in-adult-patients-with-mild-to-moderate-seborrheic-dermatitis-100624007","NCT07404033","ZYG24002 Lotion to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy in Adult Patients With Mild to Moderate Seborrheic Dermatitis","A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase Ⅰb Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Different Concentrations of ZYG24002 Lotion in Adult Patients With Mild to Moderate Seborrheic Dermatitis","Inclusion Criteria:\n\n1. Aged 18 (inclusive) to 65 (inclusive) years, of either sex. Male subjects must have no childbearing potential or agree to adopt contraceptive measures until 3 months after the end of the study; female subjects of childbearing potential must be non-pregnant and non-lactating, and adopt reliable contraceptive measures during the study period and within 3 months after the last dose.\n2. Diagnosed with seborrheic dermatitis by a dermatologist (diagnostic criteria refer to the Expert Consensus on Integrated Traditional Chinese and Western Medicine Diagnosis and Treatment of Seborrheic Dermatitis (2024 Edition) and the 2015 Asian Consensus on Seborrheic Dermatitis), with a disease duration of ≥ 3 months; baseline Investigator's Global Assessment for Seborrheic Dermatitis (IGA-SD) score (0-4 point scale) of 2 (mild) or 3 (moderate); at baseline, the overall scores for erythema and scaling are at least mild severity (score 1) respectively. The involved body surface area (BSA%) is ≤ 10%, and skin lesions are distributed in at least two anatomical sites such as the scalp, face, and trunk.\n3. No obvious signs of infection at the test site (e.g., pustules, crusts caused by bacterial infection). The subject is in good general skin condition at enrollment, with no other active skin lesions that may interfere with the clinical assessment.\n4. Has not participated in any other clinical trials or used any investigational drugs within the past 3 months.\n5. Study participants provide informed consent to participate in this study, sign the informed consent form (ICF), are able to understand the study requirements, and are willing to complete all scheduled visits and examinations in accordance with the investigator's instructions.\n\nExclusion Criteria:\n\n1. Severe active seborrheic dermatitis: IGA-SD score of 4 points or extensive skin lesions (BSA \\> 10%), accompanied by obvious exudation and infection, requiring systemic therapy. Participants whose disease activity is deemed unsuitable for study enrollment by the investigator (including but not limited to situations where 4 weeks of placebo-only treatment may lead to unacceptable disease progression).\n2. Comorbidities of other skin diseases that may interfere with study assessments, such as psoriasis, severe acne, rosacea, atopic dermatitis, etc., which would confound the observation of seborrheic dermatitis lesions.\n3. Administration of systemic glucocorticoids, systemic retinoids, immunosuppressants, oral\u002Fintravenous antifungals, phototherapy, PDE-4 inhibitors, or JAK inhibitors within 4 weeks; topical glucocorticoids, calcineurin inhibitors, PDE-4 inhibitors, antifungals, retinoids, keratolytics, selenium\u002Ftar-containing preparations on the study area within 2 weeks; any biologic agents within 6 months; or potent CYP3A4 inhibitors\u002Finducers within 4 weeks.\n4. Receipt of physical or chemical cosmetic treatments on the head and face within the past month (e.g., intense pulsed light, glycolic acid peels), resulting in temporary skin barrier dysfunction that has not yet recovered to normal.\n5. A history of known severe hypersensitivity or severe adverse reactions to ZYG24002 or its excipients.\n6. Comorbidities of other skin diseases that may increase the systemic absorption of ZYG24002, such as Netherton syndrome or erythroderma.\n7. Current use of immunosuppressants or diagnosis of immune deficiency.\n8. A history of malignancy within 5 years prior to screening or at screening.\n9. Poorly controlled chronic diseases, including but not limited to endocrine disorders (e.g., diabetes mellitus with significantly elevated fasting blood glucose and obvious clinical symptoms, hyperthyroidism); a history of severe cardiovascular and cerebrovascular diseases (e.g., myocardial infarction, stroke); active peptic ulcers or chronic inflammatory bowel disease, etc.\n10. Abnormal liver function: ALT or AST \\> 2 × upper limit of normal (ULN), or total bilirubin \\> 1.5 × ULN at screening; abnormal renal function: serum creatinine \\> 1.5 × ULN; or other clinically significant abnormal laboratory findings that are deemed unsuitable for enrollment by the investigator.\n11. Human immunodeficiency virus (HIV) infection; active hepatitis C virus (HCV) infection (anti-HCV positive); active hepatitis B virus (HBV) infection (HBV-DNA \\> 2000 IU\u002FmL or 10⁴ CPs\u002FmL); or positive treponema pallidum antibody with evidence of active infection.\n12. Diagnosis of psychiatric or neurological disorders that may affect compliance or increase study-related risks.\n13. Pregnancy, lactation, or planned pregnancy; female subjects of childbearing potential who have not initiated reliable contraceptive measures at least 30 days prior to the first dose and who cannot commit to maintaining such measures for 3 months after the last dose.\n14. Diagnosis of alcohol or addictive substance dependence within the past 12 months, or other conditions that the investigator believes may compromise study compliance.\n15. Any other conditions that the investigator deems may interfere with study results or pose an unacceptable safety risk to the participant.",{"count":54,"type":21},48,[24],"This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase Ib clinical trial conducted in adult patients with mild to moderate seborrheic dermatitis (IGA-SD score of 2-3 points). The study aims to evaluate the safety, tolerability, and steady-state pharmacokinetic (PK) profiles of three concentrations (0.5%, 0.75%, and 1.0%) of ZYG24002 Lotion following continuous topical application once daily (QD) or twice daily (BID) for 28 days, and to conduct a preliminary exploration of the drug's efficacy.",[58],"Seborrheic Dermatitis",[60],"seborrheic dermatitis","RECRUITING","2026-06-16",{"date":64,"type":37},"2026-06-17",{"date":66,"type":37},"2026-04-24",{"date":68,"type":21},"2026-12-31",{"name":43,"class":44},""]